Multicenter Study Assessing the Efficacy & Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus With Active Lupus Erythematosus Specific Skin Lesion

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01551069
• Date of registration: 08/03/2012
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: Multicenter Study Assessing the Efficacy & Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus With Active Lupus Erythematosus Specific Skin Lesion
• Scientific title: A Randomized, Double Blind, Baseline Controlled Study Using Placebo as Reference for Assessing the Efficacy and Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus in the Presence of Active Lupus Erythematosus Specific Skin Lesion
• Date of first enrolment: March 2012
• Target sample size: 103
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01551069
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Japan

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion criteria

Inclusion criteria :

- Patients diagnosed as cutaneous lupus erythematosus (CLE)

Exclusion criteria:

- Patients receiving corticosteroid more than 15mg/day of the equivalent dose of
prednisolone.

- Patients whose CLASI activity scores were less than 4 point at the initiation of
Screening (Visit 1) and Day1 (Visit 2) (evaluated by a dermatology specialist).

- Patients whose fluctuations of CLASI activity scores were =20% between Visit 1 and
Visit 2 (evaluated by a dermatology specialist). The above information is not
intended to contain all considerations relevant to a patient's potential
participation in a clinical trial.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus

Intervention(s)

Drug: hydroxychloroquine (Z0188)

Drug: Placebo

Primary Outcome(s)

A change in CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index) activity score [Time Frame: from baseline (at visit 2) to 16 weeks treatment (at visit 6)]

Secondary Outcome(s)

Global assessment by patient (skin) [Time Frame: 3 timepoints during 52 weeks]

Number of patients with serious adverse events / adverse events [Time Frame: up to a maximum of 59 weeks]

Ophthalmologic examination (visual acuity examination, slit-lamp examination, funduscopic examination, visual field examination and color vision examination) [Time Frame: 14 timepoints during 52 weeks]

BILAG (British Isles Lupus Assessment Group) index to be conducted in patients complicated with SLE [Time Frame: 7 timepoints during 52 weeks]

Dose reduction of concomitant corticosteroid [Time Frame: From 16 weeks to 55 weeks after the initiation of the treatment]

Immunological parameters [Time Frame: up to maximum of 13 timepoints during 52 weeks]

QOL related to skin manifestations (skindex-29) [Time Frame: 4 timepoints during 52 weeks]

A change in CLASI activity score [Time Frame: from baseline (at visit 2) to 52 weeks treatment (at visit 15)]

Global assessment by investigator (skin and other) [Time Frame: 3 timepoints during 52 weeks]

RAPID 3 (Routine assessment of patient index data 3) to be conducted in patients complicated with SLE : daily life activity, pain associated with the original disease, patient's severity related to the original disease [Time Frame: 7 timepoints during 52 weeks]

Secondary ID(s)

EFC12368

U1111-1126-8072

Source(s) of Monetary Support

Please refer to primary and secondary sponsors